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Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653172
First Posted: April 4, 2008
Last Update Posted: January 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novexel Inc
  Purpose
The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults

Condition Intervention Phase
Community Acquired Pneumonia Drug: NXL103 Drug: comparator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multicenter, Randomized, Double Dummy, Three-Arm Parallel-Group Comparative Study of the Efficacy, Safety and Tolerance of Oral NXL 103 Versus Oral Comparator in the Treatment of Community-Acquired Pneumonia in Adults

Resource links provided by NLM:


Further study details as provided by Novexel Inc:

Primary Outcome Measures:
  • Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ]

Secondary Outcome Measures:
  • Evaluate bacteriological outcome [ Time Frame: early follow up visit (day 14 to 21) ]
  • Evaluate safety [ Time Frame: first dose, throughout treatment, and to follow up visit ]

Enrollment: 302
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NXL103
Drug: NXL103
500mg orally twice daily
Active Comparator: 3 Drug: comparator
comparator twice daily
Experimental: 2
NXL103
Drug: NXL103
600mg orally twice daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Community acquired pneumonia

Exclusion Criteria:

  • severe CAP
  • respiratory infections attributed to sources other than community acquired bacterial infection
  • concomitant pulmonary disease
  • history of hypersensitivity to study medication, macrolide or beta lactam antibiotics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653172


  Show 60 Study Locations
Sponsors and Collaborators
Novexel Inc
  More Information

Responsible Party: Dr. Carole A. Sable Chief Medical Officer, Novexel SA
ClinicalTrials.gov Identifier: NCT00653172     History of Changes
Other Study ID Numbers: NXL103/2001
First Submitted: April 1, 2008
First Posted: April 4, 2008
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by Novexel Inc:
CAP
community acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptogramin A
Anti-Bacterial Agents
Anti-Infective Agents